Clavicle Plate 3.5mm 21122-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09120034305214), received between May 2, 2019 and May 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K050852); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Fracture

  IT WAS REPORTED THAT A CLAVICLE PLATE 10-HOLE BROKE APPROX. 3,5 MONTHS POST-OP.

  Patient problems: Loss of fracture reduction

  MAUDE report 25148000 ↗
• MalfunctionMay 2, 2019Fracture; Fracture

  IT WAS REPORTED THAT A CLAVICLE PLATE, MEDIAL, 3.5MM, 10-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2017. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017.

  Patient problems: No Information

  MAUDE report 8572271 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050852. One submission often covers many models, so check the product and lot details in each record.

• Z-1593-2026 · Jan 23, 2026 · Open, Classified
  Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-1